# Whole Blood Point of Care Metabolic Measurement

> **NIH NIH R44** · SEQUITUR HEALTH CORP. · 2023 · $703,162

## Abstract

Project Summary
This SBIR Phase II project will translate Phase I technical innovations in sensor materials and a prototype
device into a fully functional point of care technology for whole blood biomarker monitoring. It will culminate in a
complete draft of a 510(k) clearance application to the U.S. Food & Drug Administration (FDA). Currently, no
commercial FDA cleared point of care device is available for direct measurement of this biomarker in whole
blood. All large clinical instruments require separation of plasma from whole blood via centrifugation prior to
measurement. Further, current clinically used measurements, which rely on plasma separated from whole
blood, suffer from inaccurate results from pre-analytical variability in sample handling.
Phase I completed technical innovations supported by the National Science Foundation yielded 1) increased
sensor specificity, by eliminating signals from interferents, 2) increased sensor sensitivity through sensing
material improvements, and 3) direct point of care measurement from whole blood, instead of plasma
separated ex-situ from the measurement device which eliminated pre-analytical variability in sample handling.
This novel point of care whole blood measurement device will be used to improve at-home management of the
~10,000 people living with these rare metabolic disorders and as a newborn screening to improve identification
of the ~1/3500 newborns with rare metabolic disorders out of the 3.9 million annual births in the United States.
Ultimately, manufacturing of consumable, single use sensors and sensor readers will create new jobs in the
United States.
In this Direct Phase II project, Sequitur Health Corp. will partner with Arizona State University and Mayo Clinic
to innovate a process for mass production of the laboratory-scale sensors developed from the Phase I
project and subsequently analytically and clinically validate the mass-produced sensors and reader
technology for FDA 510(k) clearance.

## Key facts

- **NIH application ID:** 10691330
- **Project number:** 5R44HD107897-03
- **Recipient organization:** SEQUITUR HEALTH CORP.
- **Principal Investigator:** Marylaura Lind Thomas
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $703,162
- **Award type:** 5
- **Project period:** 2021-09-17 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10691330

## Citation

> US National Institutes of Health, RePORTER application 10691330, Whole Blood Point of Care Metabolic Measurement (5R44HD107897-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10691330. Licensed CC0.

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